CORRECTION: The High Court has ruled largely in favour of the National Institute for Health and Clinical Excellence in Eisai/Pfizer’s challenge against its guidance recommending Alzheimer’s disease drugs only for patients with moderate disease.

NICE first ruled against the use of the acetyl cholinesterase inhibitors Aricept (donepezil), sold by Pfizer and Eisai, Novartis’ Exelon (rivastigmine) and Shire’s Reminyl (galantamine) on the NHS in March 2005, acknowledging that they were clinically effective, but stating they could not be deemed cost effective.

Widespread public condemnation, however, lead to this decision being partly overturned in November 2006, allowing patients with moderate disease access to the drugs, but a subsequently unsuccessful appeal to extend this to patients with mild Alzheimer’s drove Eisai/Pfizer as the lead claimant to pursue the first-ever judicial review against a NICE decision.

The four-day, landmark hearing in June marked the climax of an intense campaign involving around 11,000 objections, five appeals and nationwide protests against the decision, during which it was argued that NICE had “drastically underestimated costs of care” and had “overlooked carer benefits” when drawing up its cost-effectiveness decision for Aricept, Exelon and Reminyl.

Breach of Discrimination Act

But the court sided with the Institute in five out of the six grounds listed in the case, although it found that NICE had breached its duties under the Disability Discrimination Act by not adequately clarifying its guidance for people with learning difficulties or language limitations.

Speaking at a media briefing today, NICE chairman Michael Rawlins said it is “ratifying to know that our procedures meet the standards of the High Court.”

The Association of the British Pharmaceutical Industry also welcomed

the outcome of the judicial review, but expressed “disappointment that the full process by which NICE arrives at its decisions should not be made public for scrutiny by patients, the pharmaceutical industry and other stakeholders.”

“There is a need for complete transparency when NICE is making important

decisions that affect people’s health. Everyone ought to know on what

basis such crucial decisions are made, and I therefore find the court’s

decision very disappointing,” explained Dr Richard Barker, Director General of the ABPI.

Currently 700,000 people in the UK have a form of dementia, and more than half have Alzheimer's disease. In less than 20 years, says the Alzheimer’s Society, nearly a million people will be living with dementia and this will soar to 1.7 million people by 2051.

Further details to follow next week